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Orthostatic HypotensionPhase 3306A/306BNCT01176240

A Two Part Study (306A/306B) to Assess Droxidopa in Treatment of NOH in Patients With Parkinson's Disease

A Phase 3 study testing Droxidopa in people with Orthostatic Hypotension and Parkinson's Disease, run by Chelsea Therapeutics at 60 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a study to evaluate the effects of an investigational drug, Droxidopa, in participants with neurogenic orthostatic hypotension (NOH), associated with Parkinson's disease. Droxidopa is being studied to determine the effects on blood pressure changes upon standing up (orthostatic challenge). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Orthostatic Hypotension, Parkinson's Disease
What is being tested?
Droxidopa
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
225 participants
Where
60 sitesUnited States
Study dates
Jun 2010to Nov 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years or over
  • Clinical diagnosis of Parkinson's disease
  • Clinical diagnosis of symptomatic neurogenic orthostatic hypotension
  • At their baseline visit (Visit 2), patients must demonstrate:
  • a score of at least 3 or greater on the OHQ composite
  • a score of at least 3 or greater on the clinician CGI-S
  • a fall of at least 20 mmHg in their systolic blood pressure, or 10 mmHg in their diastolic blood pressure, within 3 minutes of standing 4. Provide written informed consent to participate in the study and understand that they may withdraw their consent at any time without prejudice to their future medical care

Who cannot join

  • Score of 23 or lower on the mini-mental state examination (MMSE)
  • Concomitant use of vasoconstricting agents for the purpose of increasing blood pressure;
  • Patients taking vasoconstricting agents such as ephedrine, dihydroergotamine, or midodrine must stop taking these drugs at least 2 days or 5 half-lives (whichever is longer) prior to their baseline visit (Visit 2) and throughout the duration of the study
  • Concomitant use of anti-hypertensive medication for the treatment of essential hypertension
  • Have changed dose, frequency or type of prescribed medication, within two weeks of baseline visit (Visit 2) with the following exceptions:
  • Vasoconstricting agents such a ephedrine, dihydroergotamine, or midodrine
Show all 24Show fewer
  • Short courses (less than 2 weeks) of medications or treatments that do not interfere with, or exacerbate the patient's condition under study (e.g. antibiotics)
  • Known or suspected alcohol or substance abuse within the past 12 months (DSM-IV definition of alcohol or substance abuse)
  • Women who are pregnant or breastfeeding
  • Women of child bearing potential (WOCP) who are not using at least one method of contraception with their partner
  • Male patients who are sexually active with a woman of child bearing potential (WOCP) and not using at least one method of contraception
  • Untreated closed angle glaucoma, or treated closed angle glaucoma that, in the opinion of an ophthalmologist, might result in an increased risk to the patient
  • Sustained severe hypertension (BP ≥ 180 mmHg systolic or ≥ 110 mmHg diastolic in the seated or supine position which is observed in 3 consecutive measurements over an hour)
  • Any significant uncontrolled cardiac arrhythmia
  • History of myocardial infarction, within the past 2 years
  • Current unstable angina
  • Congestive heart failure (NYHA Class 3 or 4)
  • Diabetic autonomic neuropathy
  • History of cancer within the past 2 years other than a successfully treated, non-metastatic cutaneous squamous cell or basal cell carcinoma or cervical cancer in situ
  • Gastrointestinal condition, which in the Investigator's judgment, may affect the absorption of study drug (e.g. ulcerative colitis, gastric bypass)
  • Any major surgical procedure within 30 days of the baseline visit (Visit 2)
  • Previously treated with droxidopa
  • Currently receiving any investigational drug or have received an investigational drug within 30 days of the baseline visit (Visit 2)
  • Any condition or laboratory test result, which in the Investigator's judgment, might result in an increased risk to the patient, or would affect their participation in the study. Additionally the Investigator has the ability to exclude a patient if for any reason they feel the subject is not a good candidate for the study or will not be able to follow study procedures.

Trial locations and contacts

60 sites in 1 country.

60 sites in 1 country

United States60 sites

  • Neurology Neurodiagnostic Lab

    Alabaster, Alabama, 35007

  • Upstate Clinical Research, LLC

    Albany, New York, 12205

  • Asheville Neurology Specialists, PA

    Asheville, North Carolina, 28806

  • Emory University

    Atlanta, Georgia, 30329

  • Wellness and Research Center

    Belvidere, New Jersey, 07823

  • Parkinson's Disease & Movement Disorder Disoder

    Boca Raton, Florida, 33486

  • Harvard Vanguard Medical Associates

    Boston, Massachusetts, 02215

  • Community Research

    Cincinnati, Ohio, 45227

  • Ohio State University Medical Center

    Columbus, Ohio, 43210

  • David L. Kreitzman, M.D., PC

    Commack, New York, 11725

  • UT Southwestern Medical Center at Dallas

    Dallas, Texas, 75390-9063

  • Neurology Specialists of Decatur Research Center

    Decatur, Georgia, 30033

  • Alexian Brothers Hospital Network

    Elk Grove Village, Illinois, 60007

  • Associated Neurologist of Southern Connecticut, PC

    Fairfield, Connecticut, 06824

  • Neurological Physicians of Arizona

    Gilbert, Arizona, 85234

  • Guilford Neurologic Associates

    Greensboro, North Carolina, 27405

  • North Oaks Health System

    Hammond, Louisiana, 70403

  • Hartford Hospital

    Hartford, Connecticut, 06106

  • Ilumina Clinical Associates

    Johnstown, Pennsylvania, 15904

  • Kingston Neurological Associates

    Kingston, New York, 12401

  • Caring Clinical Research Incorporated

    Laguna Hills, California, 92653

  • University of Nevada School of Medicine

    Las Vegas, Nevada, 89102

  • AdvanceMed Research

    Lawrenceville, New Jersey, 08648

  • Eastern Connecticut Neurology Specialists

    Manchester, Connecticut, 06040

  • Pharmax Research Clinic, LLC

    Miami, Florida, 33126

  • Parker Jewish Institute For Health Care and Rehabilitation Foundation

    New Hyde Park, New York, 11040-1433

  • Beth Israel Medical Center

    New York, New York, 10003

  • New York University

    New York, New York, 10016

  • Hoag Memorial Hospital, Presbyterian

    Newport Beach, California, 92663

  • Detroit Clinical Research Center

    Novi, Michigan, 48377

  • Gulf Coast Neurology Center, PLLC

    Ocean Springs, Mississippi, 39564

  • Neurology Associates of Ormond Beach

    Ormond Beach, Florida, 32174

  • Neurosearch - Pasadena

    Pasadena, California, 91105

  • Xenoscience

    Phoenix, Arizona, 85004

  • Barrow Neurology Clinic

    Phoenix, Arizona, 85013

  • Clinical Trials Research Services LLC

    Pittsburgh, Pennsylvania, 15206

  • Neurostudies Inc.

    Port Charlotte, Florida, 33952

  • Parkinson's Disease Treatment Center of Southwest Florida

    Port Charlotte, Florida, 33980

  • Alliance Clinical Research, LLC

    Poway, California, 92064

  • Neurosearch, Inc.

    Reseda, California, 91335

  • Neurological Associates, Inc.

    Richmond, Virginia, 23226

  • Prism Research Group

    Rome, Georgia, 30165

  • JM Neuroscience Research

    Salt Lake City, Utah, 84108

  • Lovelace Scientific Research

    Sarasota, Florida, 34233

  • Banner Health

    Sun City, Arizona, 85351

  • Neurological Care of CNY

    Syracuse, New York, 13210

  • Tampa General University of South Florida

    Tampa, Florida, 33606

  • University of Toledo

    Toledo, Ohio, 43614

  • Shore Neurology

    Toms River, New Jersey, 08755

  • Precise Clinical Research

    Topeka, Kansas, 66604

  • Northern Michigan Neurology

    Traverse City, Michigan, 49684

  • Center for Neurosciences

    Tucson, Arizona, 85718

  • Northwest Neuro Specialists P.L.L.C.

    Tucson, Arizona, 85741

  • Movement Disorder Clinic of Oklahoma PLLC

    Tulsa, Oklahoma, 74136

  • Neurosearch II, Inc.

    Ventura, California, 93003

  • Vero Neurology

    Vero Beach, Florida, 32960

  • Sentara Neurology Specialists

    Virginia Beach, Virginia, 23456

  • Premiere Research Institute

    West Palm Beach, Florida, 33407

  • Neurology Consultants Medical Group

    Whittier, California, 90606

  • Clinical Trials of America Inc

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A Multi-center, Double-blind, Randomized, Parallel-Group, Placebo-Controlled Study to Assess the Clinical Effect of Droxidopa in the Treatment of Symptomatic Neurogenic Orthostatic Hypotension in Patients With Parkinson's Disease

This is a study to evaluate the effects of an investigational drug, Droxidopa, in participants with neurogenic orthostatic hypotension (NOH), associated with Parkinson's disease. Droxidopa is being studied to determine the effects on blood pressure changes upon standing up (orthostatic challenge). Symptoms and activity measurements, including patient reported falls, will be evaluated to determine the effectiveness of the study drug.

Symptoms of NOH may include any of the following:

Read more
  • Dizziness, light-headedness, feeling faint or feeling like you may blackout
  • Problems with vision (blurring, seeing spots, tunnel vision, etc.)
  • Weakness
  • Fatigue
  • Trouble concentrating
  • Head \& neck discomfort (the coat hanger syndrome)
  • Difficulty standing for a short time or a long time
  • Trouble walking for a short time or a long time

The study duration is a maximum of approximately 14 weeks including up to 2 weeks for screening, up to 2 weeks for proper dose finding, followed by an 8 week treatment period and a follow-up visit after 2 weeks. A sufficient number of patients will be screened to allow approximately 211 randomized patients. An extension study is also available to continue treatment if determined appropriate by the study doctor. This Study is NCT01132326 sponsored by Chelsea Therapeutics and is enrolling by invitation only.

Read the detailed description

Systolic blood pressure is transiently and minimally decreased in healthy individuals upon standing. Normal physiologic feedback mechanisms work through neurally-mediated pathways to maintain the standing blood pressure, and thus maintain adequate cerebral perfusion. The compensatory mechanisms that regulate blood pressure upon standing are dysfunctional in subjects with orthostatic hypotension (OH), a condition that may lead to inadequate cerebral perfusion with accompanying symptoms of syncope, dizziness or lightheadedness, unsteadiness and blurred or impaired vision, among other symptoms.

Orthostatic hypotension may be a severely disabling condition which can seriously interfere with the quality of life of afflicted subjects. Currently available therapeutic options provide some symptomatic relief in a subset of subjects, but are relatively ineffective and are often accompanied by severe side effects that limit their usefulness. Support garments (tight-fitting leotard) may prove useful in some subjects, but is difficult to don without family or nursing assistance, especially for older subjects. Midodrine, fludrocortisone, methylphenidate, ephedrine, indomethacin and dihydroergotamine are among some of the pharmacological interventions that have been used to treat orthostatic hypotension, although only midodrine is specifically approved for this indication. The limitations of these currently available therapeutic options, and the incapacitating nature and often progressive downhill course of disease, point to the need for an improved therapeutic alternative.

Symptomatic OH in patients with Parkinson's disease is thought to be a consequence of norepinephrine depletion leading to low systolic blood pressure (SBP) and cerebral-hypoperfusion (reduced blood flow to the brain). Therapy with droxidopa results in increased levels of norepinephrine which should lead to improved SBP and cerebral perfusion thereby reducing the signs and symptoms of NOH. The present study will evaluate the clinical benefit in NOH patients with PD treated with droxidopa compared to those treated with placebo.

Participation in the study will last a maximum of 14 weeks consisting of a 2 week (maximum) screening/baseline period; a 2 week (maximum) double-blind dose titration; an 8 week double-blind placebo-controlled treatment period; and a 2 week follow-up period. An extension study is also available to continue treatment if determined appropriate by the study doctor. This Study is NCT01132326 sponsored by Chelsea Therapeutics and is enrolling by invitation only.

Droxidopa:

Droxidopa [also, known as L-threo-3,4-dihydroxyphenylserine, L-threo-DOPS, or L-DOPS] is the International non-proprietary name (INN) for a synthetic amino acid precursor of norepinephrine (NE), which was originally developed by Sumitomo Pharmaceuticals Co., Limited, Japan. It has been approved for use in Japan since 1989. Droxidopa has been shown to improve symptoms of orthostatic hypotension that result from a variety of conditions including Shy Drager syndrome (Multiple System Atrophy), Pure Autonomic Failure, and Parkinson's disease. There are four stereoisomers of DOPS; however, only the L-threo-enantiomer (droxidopa) is biologically active. Stereoisomers and enantiomers are compounds that have the same chemical elements; however, they may react differently as the elements are positioned in different locations.

The exact mechanism of action of droxidopa in the treatment of symptomatic NOH has not been precisely defined; however, its NE replenishing properties with concomitant recovery of decreased noradrenergic activity are considered to be of major importance.

Droxidopa has been marketed in Japan since 1989. Data from clinical studies and post-marketing surveillance programs conducted in Japan show that the most commonly reported adverse drug reactions with droxidopa are increased blood pressure, nausea, and headache. In clinical studies, the prevalence and severity of droxidopa adverse effects appear to be similar to those reported by the placebo control arm.

Being tested
Droxidopa, Placebo
Keywords
lightheadedness, unsteadiness, dizziness, weak, fatigue, concentration, head & neck pain, standing/walking for a short time, standing/walking for a long time, Neurogenic Orthostatic Hypotension, falls, NOH, Parkinson's disease, weakness
Medical subject headings
Hypotension, Orthostatic, Parkinson Disease, Dizziness, Asthenia, Fatigue, Neck Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DroxidopaDrug

    Also called Northera, L-DOPS, L-threo-dihydroxyphenylserine, SM-5688

    100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment

  • PlaceboOther

    Also called Mannitol, Sugar Pill

    Placebo

Study groups in NCT01176240
Study groupRoleWhat they receive
DroxidopaExperimentaldroxidopa active drug
Receives: Drug: Droxidopa
PlaceboPlacebo comparatorPlacebo matched control
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 306A Efficacy: Change in Orthostatic Hypotension Questionnaire Score (OHQ)

    The primary efficacy endpoint for 306A is the relative mean change in Orthostatic Hypotension Questionnaire (OHQ) composite score from baseline to end of study. The OHQ is the average of two sub-scales, the Orthostatic Hypotension Symptom Assessment Scale (OHSA) and the Orthostatic Hypotension Daily Activities Scale (OHDAS). Each asks the patient to rate their symptoms or disease impact over the past week. The OHSA sub-scale is the average of six items: 1) Dizziness, lightheadedness, feeling faint or feeling like you might black out; 2) Problems with vision; 3) Weakness; 4) Fatigue; 5) Trouble concentrating; and 6) Head/neck discomfort. The OHDAS sub-scale is the average of four items: 1) Standing for a short time; 2) Standing for a long time; 3) Walking for a short time; and 4) Walking for a long time. Each item is scored on a Likert scale from 0 to 10, with 10 being the most severe.

    For the change from baseline, negative numbers represent improvement from baseline in OHQ score.

    Measured: Baseline, Week 8

  2. 306B Efficacy: Change in Dizziness/Lightheadedness/Feeling Faint/Feeling Like You Might Black Out (OHSA Item 1)

    OHSA item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at Week 1 minus score at baseline. A negative score indicates an improvement in symptoms during the double-blind randomized phase relative to value at baseline.

    Measured: Baseline, Week1

Secondary outcomes (6)

  1. 306B Efficacy: Change in OHSA Item 1 From Baseline to Week 2 (Visit 5)

    OHSA item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at Week 2 minus score at baseline. A negative score indicates an improvement in symptoms during the double-blind randomized phase relative to value at baseline.

    Measured: Baseline, Week2

  2. 306B Efficacy: Change in OHSA Item 1 From Baseline to Week 4 (Visit 6)

    OHSA item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at Week 4 minus score at baseline. A negative score indicates an improvement in symptoms during the double-blind randomized phase relative to value at baseline.

    Measured: Baseline, Week4

  3. 306B Efficacy: Change in Systolic Blood Pressure (SBP) Measurements Post Standing From Baseline to Week 1

    Measure: Lowest standing systolic blood pressure reading of immediately post standing and 3 minutes post standing. Change: standing systolic blood pressure at Week 1 (Visit 4) minus standing systolic blood pressure at baseline. A positive score indicates an improvement in standing systolic blood pressure during the double-blind randomized phase relative to value at baseline.

    Measured: Baseline, Week 1

  4. 306B Efficacy: Change in OHSA Item 1 From Baseline to Week 8 (Visit 7)

    OHSA item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at Week 8 minus score at baseline. A negative score indicates an improvement in symptoms during the double-blind randomized phase relative to value at baseline.

    Measured: Baseline, Week 8

  5. 306B Efficacy: Rate of Patient Reported Falls

    The average number of patient reported falls per week.

    Measured: up to 10 weeks

  6. 306B Efficacy: Change in Orthostatic Hypotension Questionnaire Score (OHQ)

    The relative mean change in Orthostatic Hypotension Questionnaire (OHQ) composite score from baseline to end of study. The OHQ is the average of two sub-scales, the Orthostatic Hypotension Symptom Assessment Scale (OHSA) and the Orthostatic Hypotension Daily Activities Scale (OHDAS). Each asks the patient to rate their symptoms or disease impact over the past week. The OHSA sub-scale is the average of six items: 1) Dizziness, lightheadedness, feeling faint or feeling like you might black out; 2) Problems with vision; 3) Weakness; 4) Fatigue; 5) Trouble concentrating; and 6) Head/neck discomfort. The OHDAS sub-scale is the average of four items: 1) Standing for a short time; 2) Standing for a long time; 3) Walking for a short time; and 4) Walking for a long time. Each item is scored on a Likert scale from 0 to 10, with 10 being the most severe.

    For the change from baseline, negative numbers represent improvement from baseline in OHQ score.

    Measured: Baseline, Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2010 (estimated)
  2. Study startJun 2010
  3. Primary completionOct 2012
  4. Study completionNov 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
225 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01176240
Sponsor's protocol ID
Droxidopa NOH306 (306A / 306B)
Acronym
306A/306B
Status last verified
Apr 2014
First submitted
30 Jul 2010
Last updated
20 May 2014
Data monitoring committee
Yes

Publications

  • Birkmayer W, Birkmayer G, Lechner H, Riederer P. DL-3,4-threo-DOPS in Parkinson's disease: effects on orthostatic hypotension and dizziness. J Neural Transm. 1983;58(3-4):305-13. doi: 10.1007/BF01252816.

    PubMed 6420517

  • Movement Disorder Society Task Force on Rating Scales for Parkinson's Disease. The Unified Parkinson's Disease Rating Scale (UPDRS): status and recommendations. Mov Disord. 2003 Jul;18(7):738-50. doi: 10.1002/mds.10473.

    PubMed 12815652

  • Goldstein DS, Pechnik S, Holmes C, Eldadah B, Sharabi Y. Association between supine hypertension and orthostatic hypotension in autonomic failure. Hypertension. 2003 Aug;42(2):136-42. doi: 10.1161/01.HYP.0000081216.11623.C3. Epub 2003 Jun 30.

    PubMed 12835329

  • Kachi T, Iwase S, Mano T, Saito M, Kunimoto M, Sobue I. Effect of L-threo-3,4-dihydroxyphenylserine on muscle sympathetic nerve activities in Shy-Drager syndrome. Neurology. 1988 Jul;38(7):1091-4. doi: 10.1212/wnl.38.7.1091.

    PubMed 3133573

  • Kaufmann H, Saadia D, Voustianiouk A, Goldstein DS, Holmes C, Yahr MD, Nardin R, Freeman R. Norepinephrine precursor therapy in neurogenic orthostatic hypotension. Circulation. 2003 Aug 12;108(6):724-8. doi: 10.1161/01.CIR.0000083721.49847.D7. Epub 2003 Jul 28.

    PubMed 12885750

  • Yanagisawa N, Ikeda S, Hashimoto T, Hanyu N, Nakagawa S, Fujimori N, Ushiyama M. [Effects of L-threo-Dops on orthostatic hypotension in Parkinson's disease]. No To Shinkei. 1998 Feb;50(2):157-63. Japanese.

    PubMed 9513205

  • Malamut, R., Freeman, R., Gilden, J., Tulloch, J., Kaufmann, H., 2005. A multi-center, double-blind, randomized, placebo controlled, cross-over study to assess the clinical benefit of midodrine in patients with neurogenic orthostatic hypotension. Clin. Auto. Res. 15 (5) 337[abstract].

  • Narabayashi, H., Nakanishi, T., Kanazawa, I., Yoshida, M., Mizuno, Y., Yanagisawa, N., Kondo, T. 1987. Clinical effects of L-threo-3,4-dihydroxyphenylserine in Parkinson's disease and Parkinson syndrome: Results of multi-center open study at 45 institutions. Yakuri To Chiryo (Jpn. Pharmacol. Ther.) 15(Suppl. 2):411 to 443.

  • Sobue, I., Senda, Y., Suzuki, T., Narabayashi, I., Hirayama, K. 1987. Clinical effects of L-threo-3,4-dihydroxyphenylserine on orthostatic hypotension in Shy-Drager Syndrome and its related diseases. Shinkei Naika Chiryo [Neurol. Ther.] 4(2):199-208.

  • Heller GZ, Couturier DL, Heritier SR. Beyond mean modelling: Bias due to misspecification of dispersion in Poisson-inverse Gaussian regression. Biom J. 2019 Mar;61(2):333-342. doi: 10.1002/bimj.201700218. Epub 2018 Jul 12.

    PubMed 30003579

  • Biaggioni I, Arthur Hewitt L, Rowse GJ, Kaufmann H. Integrated analysis of droxidopa trials for neurogenic orthostatic hypotension. BMC Neurol. 2017 May 12;17(1):90. doi: 10.1186/s12883-017-0867-5.

    PubMed 28494751

  • Francois C, Rowse GJ, Hewitt LA, Vo P, Hauser RA. Analysis of number needed to treat for droxidopa in patients with symptomatic neurogenic orthostatic hypotension. BMC Neurol. 2016 Aug 18;16(1):143. doi: 10.1186/s12883-016-0665-5.

    PubMed 27538531

  • Hauser RA, Hewitt LA, Isaacson S. Droxidopa in patients with neurogenic orthostatic hypotension associated with Parkinson's disease (NOH306A). J Parkinsons Dis. 2014;4(1):57-65. doi: 10.3233/JPD-130259.

    PubMed 24326693

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Droxidopa in people with Orthostatic Hypotension and Parkinson's Disease, run by Chelsea Therapeutics at 60 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

306A Efficacy: Change in Orthostatic Hypotension Questionnaire Score (OHQ) (time frame: Baseline, Week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01176240, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2014.

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